Kornimate/medical-research-clean huggingface dataset:
study to assess the efficacy & safety of khk4951 in patients with diabetic macular edema

Conditions: Diabetic Macular Edema (DME)

Summary: the purpose of this study is to evaluate efficacy and safety of khk4951 eye drops in patients with dme.


Eligibility criteria:
inclusion criteria: * voluntary written informed consent to participate in the study * in korea, participants must be 19 years or older to be enrolled * bcva etdrs letter score of 78 letters to 35 letters as measured by the etdrs visual acuity chart in the study eye at screening * 500 μm ≥ cst ≥ 325 μm in the study eye at screening * hba1c ≤ 11% at screening exclusion criteria: * any signs of proliferative diabetic retinopathy in the study eye * history of rubeosis in the study eye * uncontrolled glaucoma in the study eye * aphakia or pseudophakia with ac-iol in the study eye * active intraocular inflammation in the study eye * any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye * history of rhegmatogenous retinal detachment in the study eye * any current or history of ocular disease other than dme that may confound assessment of the macula or affect central vision in the study eye * history of the following therapies in the study eye * history of vitrectomy surgery, submacular surgery, or other surgical intervention for dme * periocular or intraocular (sub-tenon or ivt) corticosteroids within 12 weeks prior to day 1 corticosteroids * previous intraocular device implantation except pc-iol * laser (any type) to the macular area within 12 weeks prior to day 1 * peripheral retinal photocoagulation therapy within 12 weeks prior to day 1 * previous treatment with ivt anti-vegf drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars * treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to day 1. previously treated patients who received these medications more than 12 weeks prior to day 1 can be enrolled, but the patients should be diagnosed with dme within 3 years prior to day 1 * previous use of ozurdex® or iluvien® implant * any current or history of endophthalmitis in either eye * history of idiopathic or autoimmune-associated uveitis in either eye * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
a modified minimally invasive approach towards le fort i osteotomy: a prospective study

Conditions: Jaw Abnormalities

Summary: nowadays, maxillary le fort i osteotomy is a safe and routinely performed procedure. the conventional approach is characterized by a vestibular incision extending from molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved chisel. adequate mobilization of the maxilla during le fort i osteotomy requires an effective separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone. however, as initially described by precious (1991) and later by hernandez-alfaro (2013), a true pterygomaxillary osteotomy is not necessary to achieve successful disjunction. furthermore, hernandez-alfaro combined his technique of pterygomaxillary disjunction, the so-called "twist technique", to a minimally invasive protocol, performing the complete le fort i osteotomy through a 20 to 30 mm long horizontal vestibular incision. although promising, the technique remains highly sensitive from a technical standpoint, and its true accuracy has not been comprehensively evaluated. the purpose of this study is to present and validate a minimally invasive approach towards le fort i osteotomy, using a modified pterygomaxillary (ptm) disjunction technique. the primary outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of the 3d virtual treatment planning and the 4 weeks postoperative cbct images. secondary outcomes include the surgical time necessary to complete the procedure and the presence of intraoperative and early postoperative complications.


Eligibility criteria:
inclusion criteria: * patients of all ages * patients of all genders * a le fort i osteotomy is planned, as part of a bimaxillary orthognathic procedure * the surgery is planned with 3d virtual treatment planning (maxilim v. 2.3.0.3.0.) * the planning is transferred with 3d cad/cam tooth-borne splint and vertical internal bony reference landmarks * the maxilla is repositioned first during the surgery (maxilla first sequence) exclusion criteria: * patients not eligible according to abovementioned criteria * simultaneous extraction of impacted teeth 18 and/or 28 * previous maxillary orthognathic surgery * previous surgical assisted rapid palatal expansion (sarpe) * syndromic condition, including cleft lip and palate * segmental le fort i osteotomy * adjuvant zygomatic osteotomy * maxillary impaction higher than 3 mm * maxillary advancement greater than 5 mm

Keywords: minimally invasive le fort i osteotomy 3d virtual treatment planning accuracy
complications in pediatric mechanical circulatory assistance: evaluation of infection management.

Conditions: Heart-Assist Devices; Infections; Heart Transplant Infection

Summary: heart failure is a major cause of mortality and morbidity in children. heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants. long-term mechanical circulatory support is a major advance in the management of heart failure and can provide haemodynamic support while awaiting myocardial recovery or heart transplantation. the berlin heart (bh) excor is the only long-term support system available for children. despite technical and medical advances in circulatory support, infection is a common complication and a major cause of morbidity and mortality in patients on bh. there are few studies on the management of infection with mechanical support. current ishlt (international society for heart and lung transplantation) recommendations are based on expert opinion and observational studies. some experts recommend anti-infective therapy until transplantation for specific support infections or for support-associated infections with persistent bacteraemia.


Eligibility criteria:
inclusion criteria: * patients under 18yo of age with berlin heart assisting device in hospices civils de lyon, in france. exclusion criteria: * patients over 18 yo at the time of bh assistance * unavailable documentation
tte and dysphagia in anterior cervical surgery

Conditions: Dysphagia

Summary: the purpose of this study is to evaluate if tracheal traction exercises (tte) performed prior to anterior cervical spine surgery can result in a decreased rate of dysphagia.


Eligibility criteria:
inclusion criteria: * elective anterior cervical spine surgery (c2-c7) for degenerative disc disease or myelopathy exclusion criteria: * more than four levels of fusion * trauma or urgent cases of anterior cervical spine surgery * prior anterior cervical spine surgery (a known risk factor for dysphagia), * prior neck surgery (eg. thyroidectomy) * tumors * infections * neurological disorders that can predispose to dysphagia such as parkinson's, cerebrovascular accidents (cva), alzheimer's and amyotrophic lateral sclerosis.
simulation-based study of adding video communication to dispatch instruction

Conditions: Cardiac Arrest

Summary: the purpose of this study is to determine whether adding interactive video communication to dispatch instruction improves the quality of bystander cardiopulmonary resuscitation in simulated cardiac arrests.

sudden cardiac death (scd) is a leading cause of adult death and bystander cardiopulmonary resuscitation (cpr) significantly improves survival. dispatch assistance increases the chance of bystander cpr but the quality of dispatcher-assisted cpr (da-cpr) remains unsatisfactory. this study is conducted to assess the effect of adding interactive video communication to dispatch instruction on the quality of bystander cpr, including chest compressions and rescue breathing, in simulated cardiac arrests.

Eligibility criteria:
inclusion criteria: * volunteers above 16 years of age who have not received any cpr training within the last 5 years were recruited. exclusion criteria: * healthcare providers, non-mandarin speaking individuals, and those with illness/physical conditions that prevent them from receiving telephone instructions or performing cpr were excluded.

Keywords: cardiac arrest video cell phone dispatcher-assisted cpr
gastrointestinal dysfunction during enteral nutrition in critically ill patients

Conditions: Gastrointestinal Disease; Constipation; Intolerance; Nutritional; Diarrhea

Summary: gastrointestinal (gi) motility disorders in intensive care patients remain relatively unexplored. nowadays, the frequency, risk factors and complications of gi dysfunction during enteral nutrition (en) become more questionable. our aim is to evaluate the frequency, risk factors and complications of gi dysfunction during en in the first 2 weeks of the intensive care unit (icu) stay and to identify precautions to prevent the development of gi dysfunction and avoid complications.

critical illness is typically associated with a catabolic stress state in which patients demonstrate a systemic inflammatory response coupled with complications of increased infectious morbidity, multiple organ dysfunction, prolonged hospitalization, and disproportionate mortality. suspension of feeding and the resultant inability to reach nutritional goals is one complication of gastrointestinal (gi) dysfunction, but there are others (mucosal barrier disruption, altered motility, atrophy of the mucosa, and reduced mass of gut-associated lymphoid tissue) that may explain the greater length of stay (los) and death rate with gi dysfunction. in europe and the united states, nutritional administration guidelines recommend primarily enteral nutrition (en) for hemodynamically stable intensive care unit (icu) patients. providing en in these patients has been shown to be superior to parenteral nutrition. gi complications such as constipation, delayed gastric emptying, diarrhea, and vomiting may occur in up to 50% of mechanically ventilated patients and adversely affect icu mortality and los. nevertheless, there is no consensus for obtaining a precise assessment of gi function.diagnosis of gi dysfunction in icu patients is complex and relies on clinical symptoms. lack of validated markers of gi system dysfunction is often misdiagnosed and poorly managed in the icu. the role of nutrition in critical illness is important, but there is an increasing evidence and broadening consensus that aggressive early feeding as well as prolonged underfeeding both should be avoided. avoidance of complications like malnutrition, aspiration of gastric contents, wound infections, and decubitus through gi dysfunction is an important part of management of patients with gi failure.

Eligibility criteria:
inclusion criteria: older than 18 years old. stay longer than 48 hours at icu. exclusion criteria: has enterostomy/colostomy or diagnosis of gi bleeding. prone position. laxative drug use. clostridium difficile infection positivity.

Keywords: icu
vitamin d levels in stage iv colorectal cancer patients

Conditions: Colorectal Cancer

Summary: the purpose of this study is to find out what effects, good and/or bad, vitamin d blood levels has on stage iv colorectal cancer. tbe doctors want to see if it is possible to increase low vitamin d levels into normal range using vitamin d supplements taken by mouth. low vitamin d levels have been associated with worse outcomes in persons who have cancer. low vitamin d may also cause people to have symptoms such as pain and fatigue. we want to see if increasing low vitamin d levels will help improve cancer outcomes. vitamin d is routinely repleted in all subjects known to be vitamin d deficient. therefore, the treatment given would be considered standard of care.


Eligibility criteria:
inclusion criteria: * patients with stage iv (metastatic) colorectal cancer * baseline 25-hydroxy vitamin d level \< 30 ng/ml * age ≥18 years of age exclusion criteria: * current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 3 years * albumin \< 3.2 * patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids * patients receiving phenobarbital, phenytoin, orlistat and cholestyramine * hypercalcemia (calcium \>10.5 mg/dl) * calcium x phosphorus \> 70 mg2/dl2

Keywords: vitamin d vitamin d3 colon cancer rectum cancer cholecalciferol 09-143
addressing unintentional leakage when using nasal cpap - study a

Conditions: Continuous Positive Airway Pressure; Adverse Effect; Obstructive Sleep Apnea

Summary: oral unintentional leak is a common side effect of continuous positive airway pressure (cpap) for obstructive sleep apnea (osa) treatment. management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. higher levels of cpap are associated with higher leak. in the present study, a sequential approach to control excessive unintentional leak will be tested. in study a, the reduction of therapeutic cpap level will be tested. in study b, oronasal cpap will be compared to nasal cpap with a chinstrap.

study a will consist of a cross-over controlled randomized trial to compare unintentional leak during auto-cpap and during fixed cpap after the progressive reduction of fixed cpap, starting at the 90 th percentile obtained during a period of auto-cpap. the order of interventions will be randomized. auto-cpap with a nasal mask will be used for 7 days. in the fixed cpap arm, cpap will be progressively reduced over a period of up to 21 days until leak is controlled or residual apnea-hypopnea index increases over 10 events/h. subjects that persisted with excessive leak at the end of the study a will be invited to study b.

Eligibility criteria:
inclusion criteria: * diagnosis of moderate and severe obstructive sleep apnea; * use of cpap with a nasal mask; * 95th percentile of unintentional leak from the last 7 days above 24 l/min or at least 4 sudden leak line drop events exclusion criteria: * patients who experience unintentional leakage from the mask/accessories. * diagnostic polysomnography examination with a predominance of central apnea; * patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and copd; * previous surgery for obstructive sleep apnea; * severe nasal obstruction (nose questionnaire score equal or greater then 55 points).

Keywords: cpap excessive leak obstructive sleep apnea
hydrocortisone in hormone replacement therapy for large pituitary neuroendocrine tumors

Conditions: Pituitary Adenoma; Pituitary Neuroendocrine Tumor

Summary: the goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. the main questions it aims to answer are: • does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants? researchers will compare hydrocortisone to a placebo (a look-alike substance that contains no drug) to see if hydrocortisone works to reduce the incidence of adrenal insufficiency. participants will: * take or intravenous infusion drug hydrocortisone or a placebo every day for 2 weeks * visit the clinic three months after surgery for checkups and tests * keep a diary of their symptoms


Eligibility criteria:
inclusion criteria: * (1) age range: 18-70 years old; * (2) accept pitnets patients who can be treated with endoscopic transsphenoidal surgery; * (3) the maximum diameter of the tumor is ≥ 2 centimeters; * (4) preoperative hypothalamic pituitary adrenal axis integrity; * (5) the subject or their legal representative signs the informed consent form exclusion criteria: * (1) patients with a history of cushing's disease or adrenal insufficiency; * (2) emergency and combined hormone therapy patients; * (3) pituitary stroke patients; * (4) patients lacking head magnetic resonance imaging;
antibiotic prophylaxis in rhinoplasty

Conditions: Nasal Obstruction; Nasal Surgical Procedures

Summary: this study compares the efficacy of a single intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides), alone versus both intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides) and postoperative oral dose of "cephalexin" or "clindamycin" use in nasal surgery.

the study will consist of 2 treatment arms: treatment arm a: intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. treatment arm b: intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg and postoperative oral dose of "cephalexin" 250mg every 4 hours or "clindamycin" 150mg every 6 hours, for a duration of three days.

Eligibility criteria:
inclusion criteria: adult patients (aged 18years and older) exclusion criteria: * prior rhinoplasty * any exogenous (non-nasal) grafts/implants * immune deficiency (dm, meds, other) * history of radiotherapy to nose

Keywords: rhinoplasty antibiotic prophylaxis
a nurse-led family-oriented resilience program for caregivers of community-dwelling dependent older adults

Conditions: Caregiver Burden

Summary: this is a 3-arm controlled trial. the participants are caregivers of the community-dwelling dependent older adults. there will be around 105 participants to be recruited and randomly allocated into 3 groups. caregiving training group will receive a evidence-based caregiving training delivered via home visit of community nurse. caregiving training plus family resilience group will additionally receive a structured family resilience intervetion. control group will receive usual community health care service by nurses. the primary outcomes are caregiving ability, family resilience and psychological distress, and the secondary outcomes are caregiving burden, resilience, coping, social support, and quality of life the caregivers and the older adults. the measurement will be conducted four times at baseline, after, 1-month and 3-month after intervention.


Eligibility criteria:
inclusion criteria: * ①the degree of disability of the caregiver is moderate to severe activity of daily living score above; * the primary caregivers are≥18 years old ; * the primary caregivers bear the most important care task during care, and the continuous care time are≥3 months ; -④the psychological pain thermometer score of the primary caregivers are≥5 points (the previous cross-sectional survey results showed that when the psychological pain thermometer score of the primary caregivers in disabled elderly are 5 points, the highest youden index is obtained, and the sensitivity, specificity, positive predictive value, and negative predictive value are also high. therefore, participants with scores above 5 points are screened as potential research subjects ); -⑤no cognitive impairment or language expression disorders; -⑥the primary caregivers have smart phones and can use them skillfully, and have access to the internet; -⑦voluntarily participate in this study and sign an informed consent form. exclusion criteria: * ①currently participating or having received intervention from other healthcare teams within the past three months; * there are paid personnel such as nannies participating in the care. * those who voluntarily withdrew from the research process; * during the research process, due to significant adverse events (such as death) involving disabled elderly individuals or primary caregivers, they were unable to continue participating in the study.

Keywords: family resilience caregiver distress older adults
ambulatory versus conventional approach diagnosing osa

Conditions: OSA

Summary: very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing obstructive sleep apnea (osa), identifying patients who benefit from continuous positive airway pressure (cpap), and reducing the need for polysomnography (psg). this study aims to assess the role of an ambulatory approach with home diagnostic sleep study. we hypothesize that the ambulatory approach is as good as the conventional approach in managing osa in terms of improvement of clinical outcome but the former approach will lead to substantial cost savings.

we conducted a prospective, randomized, controlled continuous positive airway pressure (cpap) parallel study on new referrals to the respiratory clinic, prince of wales hospital, with suspected obstructive sleep apnea (osas). osas was defined by apnea-hypopnea index(ahi) 5/hr or more of sleep plus excessive daytime sleepiness or two of the following symptoms: choking or gasping during sleep, recurrent awakenings from sleep, unrefreshed sleep, daytime fatigue, and impaired concentration. all patients with suspected osas underwent assessment at the clinic with the epworth sleepiness score(ess) and symptoms evaluation. patients who had ess score\>9 or at least two osas symptoms as described above were invited to join the study. they were randomized into either group a)home-based management approach or group b)hospital-based management approach by a random table by a third party not involved in the trial.

Eligibility criteria:
inclusion criteria: * symptoms of osa with home sleep study ahi \>= 15/hr. exclusion criteria: * unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure) * neuromuscular disease affecting or potentially affecting respiratory muscles * moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake oxygen saturation of \<92% * psychiatric disease that limits the ability to give informed consent or complete the study